Medical Device Software Validation

Medical device software validation is an essential component of regulatory compliance, ensuring that your software meets the necessary standards for safety, effectiveness, and quality.

As technology continues to play an increasingly important role in healthcare, proper validation becomes even more critical to ensure patient safety.

Are you looking for medical device software validation services? We have extensive experience in the field, and can provide expert guidance to ensure that your software meets all necessary regulatory requirements. Don’t hesitate to contact us for more information.

Medical Device Software Validation - QbD Group

What is Medical Device Software Validation?


Medical Device Software (MDSW) is software that is designed to be used, either alone or in combination, for a specific medical purpose as defined by the Medical Devices Regulation (MDR) or In Vitro Diagnostic Medical Devices Regulation (IVDR), or as per FDA regulations for medical devices.

Regulatory compliance requires control over medical device software, which includes verification and validation to meet the regulations and applicable standards (such as ISO13485, ISO14971, IEC 62304, and IEC 82304).

Our team provides support in developing the framework and technical documentation necessary for your medical device software. Our services are particularly helpful for medical device and in vitro diagnostic device companies, where software is an essential component of their products.

By working with us, you can ensure compliance with relevant regulations and standards, while also establishing a robust framework for the future.

The earlier you define and align your strategy with the required standards, the better prepared your company will be to meet regulatory requirements and deliver safe, effective, and high-quality products.

Why QbD Group?


Our approach emphasizes a lean and pragmatic framework that is tailored to your needs and working style, while also supporting the innovative nature of medical devices and in vitro diagnostics. With our broad knowledge and competencies, we are equipped to handle even the most recent technologies, such as AI and ML. 

As a client, you have several options to choose from based on your specific needs. These include:

  • Fully outsourcing the project to us for end-to-end support
  • Conducting a design study to identify potential areas for improvement
  • Coaching and supporting you in developing and implementing your validation strategy and approach
  • Implementing the strategy and approach you developed 
  • Broadening the Quality Management System (QMS) to include software development
  • Helping to build or review the technical documentation of the medical device or in vitro diagnostic device

We enable you to choose the level of support you need, while also ensuring that you have access to the resources and expertise necessary to achieve regulatory compliance and deliver high-quality products. 

Whether you need comprehensive validation support or targeted guidance in a specific area, our team is here to help.

Testimonial: Relu

Tailored approach


The actual approach and life cycle you want to take to validate your medical device software is up to you.

The most common and recognized software validation approach is the GAMP5 methodology.

Contact us


Don’t hesitate to contact us so we can listen to your needs and provide you with the right medical device software validation services.

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Come visit our booth at CPHI Barcelona 2023

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